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Kulzer, Inc.

Last updated September 17, 2026

What Kulzer, Inc. makes

Kulzer, Inc. manufactures dental materials including resin artificial teeth, dental composite resins, veneer resins for prostheses, polyether impression materials, and laboratory CAD/CAM dental milling systems. Their portfolio also includes dentine bonding agents and specialized dental resins for restorative and prosthetic applications.

The company’s products are classified as Class II medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. Kulzer, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Kulzer, Inc. manufacture?

Kulzer, Inc. specializes in dental materials and systems. Their portfolio includes resin artificial teeth, dental composite resins, veneer resins for dental prostheses, polyether impression materials for dental impressions, and laboratory CAD/CAM dental milling systems. They also produce dentine bonding agents and specialized resins for restorative and prosthetic dental applications, all designed for use in dental procedures.

Where is Kulzer, Inc. based?

Kulzer, Inc. is headquartered in the United States. The company focuses on developing and manufacturing dental materials and systems primarily for use in clinical and laboratory settings.

Which regulatory registries list Kulzer, Inc.’s devices?

Kulzer, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

How are Kulzer, Inc.’s devices classified under medical device regulations?

Kulzer, Inc.’s devices fall under Class II medical device classification. This classification applies to products that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as dental materials and systems used in restorative or prosthetic procedures.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 4315 S. Lafayette Blvd., SOUTH BEND, IN, 46614
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1821514
DUNS Number: —

Catalogue (6131)

Page 74 of 123

Device	Model / Reference	Registries	Class	Status
Artic	66080654	FDA UDI	Class II	Active
Flow Line Syr 2 X 1 Ml - Oa2	66000347	FDA UDI	Class II	Unknown
Mondial Compact Asst 4 drawer	66031205	FDA UDI	Class II	Unknown
Basic 8, C2 / BU, CE	56739427	FDA UDI	Class II	Unknown
Basic 6, B3 / P20, CE	56739184	FDA UDI	Class II	Unknown
Delara	66071688	FDA UDI	Class II	Active
Mondial 6, B4 / T435, CE	66975578	FDA UDI	Class II	Active
Basic 8, C4 / CU, CE	56739461	FDA UDI	Class II	Unknown
Mondial 8i, C2 / 35 U, CE	66973884	FDA UDI	Class II	Active
Artic 6, D3 / O 30, CE	66015067	FDA UDI	Class II	Active
Mondial 8i DS, A3 / 31L, CE	66986834	FDA UDI	Class II	Unknown
Memoreg 2 1 X (2 X 50 Ml)	50035517	FDA UDI	Class II	Active
Mondial 6 DS, B1 / R449, CE	66985757	FDA UDI	Class II	Unknown
Artic 8, A1 / 30 degree - 30 U, CE	66036995	FDA UDI	Class II	Active
Artic digital 8, D2 / 10 degrees-30LD, CE	66080767	FDA UDI	Class II	Active
Artic digital 8, B1 / 10 degrees-30 UD, CE	66080686	FDA UDI	Class II	Active
Signum matrix	66019693	FDA UDI	Class II	Active
Artic 6, C3 / S 40, CE	66013996	FDA UDI	Class II	Active
Artic digital 8, A2 / 10 degrees-32LD, CE	66080649	FDA UDI	Class II	Active
Mondial 8, D2 / 32L, CE	66802187	FDA UDI	Class II	Active
Artic	66080369	FDA UDI	Class II	Active
Delara	66071564	FDA UDI	Class II	Active
Venus Pearl	66048192	FDA UDI	Class II	Active
Signum Opaque F	66046832	FDA UDI	Class II	Active
Flexitime Fast&Scan Medium Flow 2x50ml	66044881	FDA UDI	Class II	Unknown
VENUS PEARL SYRINGE REFILL 1x3G C3	66048187	FDA UDI	Class II	Active
Mondial 8, D4 / 28 U, CE	66802194	FDA UDI	Class II	Active
Mondial 6 DS, A1 / S443, CE	66985581	FDA UDI	Class II	Unknown
Signum composite	66020011	FDA UDI	Class II	Active
Signum matrix	66030669	FDA UDI	Class II	Active
Premium 6, B4 / T6, CE	66007179	FDA UDI	Class II	Unknown
Mondial 6i, C2 / T2, CE	66970726	FDA UDI	Class II	Active
Mondial 8i, D4 / 33L, CE	66973923	FDA UDI	Class II	Active
Mondial 6, C2 / L341, CE	66017143	FDA UDI	Class II	Active
Mondial 6, B4 / R449, CE	66017069	FDA UDI	Class II	Active
Basic 6, D3 / U01, CE	56739255	FDA UDI	Class II	Unknown
Mondial 6, C4 / T405, CE	66017184	FDA UDI	Class II	Active
Artic 6, D4 / TO 40, CE	66014072	FDA UDI	Class II	Active
Mondial 8, A3.5 / 28 U, CE	66802122	FDA UDI	Class II	Active
Artic 8, B4 / 30 degree - 32 L, CE	66037046	FDA UDI	Class II	Active
Mondial 8i, A3.5 / 33 U, CE	66973810	FDA UDI	Class II	Active
Artic 6, D4 / T 40, CE	66014036	FDA UDI	Class II	Active
Premium 6, BL2 / L18, CE	66802945	FDA UDI	Class II	Unknown
Premium 6, BL3 / L16, CE	66802962	FDA UDI	Class II	Unknown
HeraCeram Pastenopaker gold, 2ml	66003361	FDA UDI	Class II	Unknown
Basic 6, B3 / P23, CE	56739232	FDA UDI	Class II	Unknown
Artic digital 6, A3 / O30D, CE	66983022	FDA UDI	Class II	Active
Mondial 6i, C1 / S2, CE	66970710	FDA UDI	Class II	Active
Delara	66071212	FDA UDI	Class II	Active
Mondial 6i, A3.5 / O4, CE	66970532	FDA UDI	Class II	Active

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Authorities

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FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Kulzer Gmbh HANAU Hesse · DE FEI 3005665377
Kulzer SRL Sacalaz-Judet Timis · RO FEI 3011203516